Home / Recalls / SpineFrontier, Inc. / Z-0977-2015

Z-0977-2015 Class II Terminated

Recalled by SpineFrontier, Inc. — Beverly, MA

Recall Details

Product Type
Devices
Report Date
January 21, 2015
Initiation Date
December 19, 2014
Termination Date
January 11, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 devices

Product Description

lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164

Reason for Recall

A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.

Distribution Pattern

Nationwide Distribution including TX, OH, VA, and Washington, DC.

Code Information

Lot/Serial Numbers: 06440-0000, 06441-0000, AG24

Other recalls by SpineFrontier, Inc.

  • Z-1973-2019 Class II — A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Num (June 13, 2019)
  • Z-1479-2015 Class II — SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; P (March 5, 2015)
  • Z-0553-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 (November 20, 2013)
  • Z-0576-2014 Class II — Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secur (November 20, 2013)
  • Z-0574-2014 Class II — Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secu (November 20, 2013)
  • Z-0575-2014 Class II — Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue (November 20, 2013)
  • Z-0573-2014 Class II — Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure (November 20, 2013)
  • Z-0555-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 (November 20, 2013)
  • Z-0554-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-8011 (November 20, 2013)
  • Z-0544-2014 Class II — PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw impla (October 18, 2013)